U.S. Rep. Marsha Blackburn, R-Brentwood

Written by

Josh Brown

The Tennessean

Two former top lawyers at the U.S. Food and Drug Administration said the agency could have stepped in long ago to shut down the company that sold tainted medicine linked to the national outbreak of meningitis.

New England Compounding Center, the compounding pharmacy in Massachusetts, shipped 17,676 vials of tainted spinal steroid injections to 23 states. Meningitis has stricken at least 121 people and resulted in 12 deaths, including six in Tennessee.

“The FDA should have put them out of business, and the state should have put them out of business. Neither of them did their job,” said Peter Barton Hutt, who was chief counsel at the agency in the 1970s.

In the wake of the outbreak, lawmakers this week are raising questions about the regulation of the compounding firms and whether the FDA should be given more oversight authority.

However, the FDA already has the power to rein in large-scale drug compounding companies under a 1938 law, Hutt said.

“The statute is clear,” Hutt said. “First, you can’t stockpile under any circumstances, and if there is an approved drug, you can’t compound a competing drug.”

The FDA sent a letter to the company in 2006, in which the agency warned the firm that it was not supposed to be manufacturing commercially available drugs. It also warned the firm about making medication without a prescription.

Traditionally, drug compounding was used by doctors and pharmacists as a way of providing a medication that wasn’t commercially available for individual patients.

“Unfortunately that process has sort of been hijacked by individuals who have looked at that and said, ‘Let’s set up a vague pharmacy where we can manufacture knockoffs of drugs already available,’ ” said Sheldon T. Bradshaw, another former top lawyer at the FDA.

Bradshaw said part of the reason the FDA has been reluctant to step in is a lack of resources.

“They expect state boards of pharmacies to rein this in,” he said. “State boards of pharmacies don’t get around to it.”

FDA didn't step in

While the 1938 law gave the FDA the power to regulate new drugs, Hutt said the agency chose not to step in for compounding pharmacies.

“Over the years, FDA informally developed a policy saying that compounding was acceptable if it was done for an individual patient rather than stockpiling, and it was done at the request of a licensed practitioner who was licensed in that state,” he said.

During the 1970s and 1980s, some compounding pharmacies began to manufacture drugs on larger scales and started advertising their products, Hutt said. The FDA cracked down on some of those firms and eventually worked with lawmakers to pass a law in 1997 that clarified what compounders were and weren’t allowed to do.

But in 2002, the Supreme Court struck down a portion of the law that prohibited the firms from advertising for their products under free speech concerns. As a result of that ruling, the FDA decided to defer to states to oversee the pharmacies in most cases.

Even so, the agency indicated it would consider going after the compounding pharmacies in certain cases, including when the drugs are being mass-produced and sold.

A later court ruling in 2008 confused the issue further, saying that the high court’s decision applied only to the advertising portion of the law.

But Hutt called those conflicting decisions irrelevant. He said the federal government still has oversight under the original 1938 law.

Call for oversight

Still, members of Congress from Connecticut and Massachusetts this week called for strengthening the FDA’s oversight for compounding pharmacies.

Rep. Rosa L. DeLauro, D-Conn., announced on Tuesday plans to introduce legislation intended to do that.

“Because of the current vague patchwork of federal and state oversight and regulation of these pharmacies, consumers are left at risk and often unaware of the differences between these products and others,” she wrote in a letter to Kathleen Sebelius, the secretary of health and human services.

“I believe that we must do more to ensure the safety of these products for American consumers,” DeLauro wrote.

Rep. Edward Markey, a Democrat from Massachusetts, announced Tuesday plans to introduce a measure that would require pharmacies that sell drugs across state lines to register with the FDA and comply with minimum safety standards. It also would require that patients are warned that the drugs are not approved by the FDA.

Tennessee lawmakers also cautiously weighed in, calling on businesses and government to work together to prevent contamination from happening again.

“The FDA plays a critical role in ensuring the safety of our nation’s pharmaceuticals,” U.S. Rep. Marsha Blackburn, R-Brentwood, said in a statement. “The center where these drugs originated clearly was acting outside the scope of a traditional compounding pharmacy.”

Blackburn added: “It is the responsibility of Congress along with the FDA to investigate and find out why these drugs were allowed to enter into the marketplace.”

The question of regulation also was raised by U.S. Sen. Lamar Alexander.

“We need to confirm the source of the material for this tragedy, determine whose job it is to regulate that source, and do our best to make sure this never happens again,” the Tennessee Republican said in a statement.